MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX25RW

Device Problem Medical Gas Supply Problem (2985)

Patient Problem Blood Loss (2597)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

Udi - not yet required for this product code/lot number combination, however the di portion was provided.The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed no defects.The actual sample, after having been rinsed and dried was tested for its gas transfer performance.Bovine blood was circulated in the oxygenator module.No anomalies were revealed in the gas transfer performance of the actual sample with the obtained values meeting manufacturing specification.A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction and the exact cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow".(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported insufficient gas exchange in the capiox device.Follow up communication with the user facility confirmed the following information: just 3 minutes after the start of cpb, the perfusionist found svo2 40% from oxygen saturation monitor and the arterial blood color was dark, similar to venous blood; the perfusionist had an arterial blood gas test, po2:21 mmhg, pco2:55 mmhg; at that moment the perfusionist checked the supply of oxygen and gas, the perfusionist confirmed two of them were normal; the perfusionist stopped the cpb and changed out the oxygenator at once for a competitor's brand sorin, then the situation became normal; and blood loss was reported to be unknown.A photo of the blood gas data was provided by the facility as followings: ph - 7.26, pco2 - 55 mmhg, po2 - 21 mmhg, hct - 23%, so2 - 26%.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6285819
• MDR Text Key: 66025413
• Report Number: 9681834-2017-00002
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 160701C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 70